CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report
Monarch Platform (Urology) recalled by Auris Health
Auris Health is recalling Monarch Platform (Urology), distributed nationwide in the US. The recall was initiated on 2 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0052-2025
- FDA event ID
- 95336
- Recalling firm
- Auris Health, Redwood City, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Aug 2024
- FDA classified
- 10 Oct 2024
- Reported
- 16 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Aug 2024 | Recall initiated by company | |
| 10 Oct 2024 | Classified by FDA | +69 days |
| 16 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Where it was distributed
Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Which lots are affected?
Cart Power Cord 20' 14AWG BLK, PN 304-003613-00. Tower Power Cord 20' 14AWG BLK, PN 304-003607-00. REF/UDI-DI/Serial Numbers: MON-000007/+B634MON0000070/120059, 120133, 210002; MON-000007-RFB/10810068810889/210001.
Where was it sold?
Worldwide - US Nationwide distribution including in the states of MN, FL, NC, AK, NJ, NY, VA, WI, AZ, MS, LA, MI, MA, MT, WV, GA, DE, TX, CA, OH, IN, SC, PA, CT, ND, MO, DC, IL, NE, ID, WA, TN, OR, AL, SD, CO, KY, NM, VT, MD and the countries of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95336This product is part of a recall event; the main page for the event is Monarch Platform (Endoscopy) recalled by Auris Health.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Monarch Platform (Endoscopy) recalled by Auris Health | Auris Health | Device Malfunction | Nationwide |
More recalls from Auris Health
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Monarch Platform, Bronchoscopy recalled by Auris Health | Auris Health | Device Malfunction | Nationwide |
| Device | CLASS II | Monarch Bronchoscope recalled by Auris Health | Auris Health | Packaging Defects | Nationwide |
| Device | CLASS II | Monarch Platform (Endoscopy) recalled by Auris Health | Auris Health | Device Malfunction | Nationwide |
| Device | CLASS II | Monarch Platform recalled by Auris Health | Auris Health | Device Malfunction | 34 states |
| Device | CLASS II | Monarch Platform recalled by Auris Health | Auris Health | Device Malfunction | 34 states |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |